Unique Device Identification Requirements for Convenience Kits
This guidance clarifies FDA's interpretation of convenience kit for the Unique Device Identification (UDI) system requirements. It applies to medical devices packaged together but excludes in vitro diagnostic (IVD) devices and combination products.
Recommended Actions
- Evaluate if your packaged devices meet the definition of a convenience kit according to the guidance criteria
- Ensure proper UDI labeling on the convenience kit package
- Document justification for convenience kit classification
- Submit required data to GUDID for the convenience kit
- Implement process for assigning new DIs when making changes to the kit
- Consider including DIs of individual devices in the GUDID record if individual UDIs are used
- Ensure compliance with direct marking requirements for any reusable devices within the kit
- Establish procedures to maintain UDI compliance throughout the product lifecycle
- Consider requesting exceptions or alternatives if needed under 21 CFR 801.55
Key Considerations
Labelling
- The label and device package of a convenience kit must bear a UDI
- Individual devices within a convenience kit are excepted from UDI labeling requirements if the convenience kit label bears a UDI
- Production identifiers (PIs) must be included in the convenience kit UDI as required by 21 CFR 801.40(b)
Other considerations
- A convenience kit must contain two or more different finished medical devices
- Devices must be intended to remain packaged together
- Devices must not be intended to be replaced, substituted, repackaged, sterilized, or modified before use
- The collection of devices must itself qualify as a medical device
- Changes resulting in a new version or model require a new Device Identifier (DI)
- Data submission to GUDID is required for convenience kits
Relevant Guidances
- Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
- Unique Device Identifier (UDI) Form and Content Requirements
- Unique Device Identification System: Implementation and Compliance Requirements
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
Related references and norms
- 21 CFR 801.3: Definitions
- 21 CFR 801.20: Label to bear a unique device identifier
- 21 CFR 801.30: Exceptions from UDI labeling requirements
- 21 CFR 801.40: Form of a unique device identifier
- 21 CFR 801.45: Direct marking requirements
Original guidance
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